Phase 2 results of Nicox’s NCX 470 Dolomites published in the Journal of Glaucoma
Press release Phase 2 results of Nicox’s NCX 470 Dolomites published in Glaucoma Diary
April 11, 2022 – release at 7:30 CET
Nicox S.A. (Euronext Paris: FR0013018124, COX), an international society of ophthalmology, announces today that the results of its Phase 2 Dolomites clinical trial of NCX 470 in patients with open-angle glaucoma or ocular hypertension have been released. online by the Glaucoma Diary, the official journal of the World Glaucoma Association. The publication “Randomized, controlled comparison of NCX 470 (0.021%, 0.042%, and 0.065%) and latanoprost 0.005% in patients with open-angle glaucoma or ocular hypertension: the Dolomites study”” is available by clicking here. NCX 470 is currently in two Phase 3 clinical trials.
Dolomites was a Phase 2 dose-response clinical trial comparing three strengths of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or d ocular hypertension. Consistent with earlier reported Dolomite results, NCX 470 0.065% achieved statistical superiority over latanoprost 0.005% at all time-paired points measured on Day 28, with maximal improvement in intraocular pressure (IOP) 1.4 mmHg higher than that of latanoprost. All tested concentrations of NCX 470 were statistically non-inferior to latanoprost and the dose response of NCX 470 showed improvement in IOP reduction with each increase in concentration. NCX 470 was safe and well tolerated with no serious drug-related adverse events and no evidence of treatment-related systemic side effects.
“Like present to American Glaucoma Societyin February 2020 by Dr David Wirta, the Dolomites Phase 2 the data shows that NCX470, monotherapy with a dual mechanism of action, has the potential to be a new standard of care for reducing intraocular pressure in sick with open-angle glaucoma or ocular hypertension.” mentioned Doug HubatschChief ScientificOfficer of Nicox. “We are happy to be able to share the results of this Pbase 2trial in aPeer-reviewed publication with the international glaucoma community.We look forward to the results of the next Pi have 3tests of the NCX 470 – Mont Blanc and Denali – which use a higher dose of NCX 470, based on the results of an initial adaptive dose range design phaseof the Mont Blanc trial.”
NCX 470 is currently enrolling patients in two multi-regional Phase 3 glaucoma clinical trials, Mont Blanc and Denali. The objective of these two trials is to demonstrate a statistically superior IOP reduction of NCX 470 0.1% once-daily ophthalmic solution compared to latanoprost 0.005% ophthalmic solution (first marketed as the name of Xalatan), the most prescribed prostaglandin analogue in the United States for patients with open disease. angle glaucoma or ocular hypertension. About the NCX 470 NCX 470 is a novel, potentially best-in-class, nitric oxide (NO)-donating prostaglandin analog being developed to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Glaucoma is a group of eye diseases in which the optic nerve is injured, resulting in peripheral and ultimately central visual field loss and possibly leading to blindness if left untreated. It is frequently linked to abnormally high IOP (~90% of patients) due to blockage or dysfunction of the eye’s aqueous humor drainage system at the front of the eye. In 2020, global sales of treatments targeting glaucoma were over $6.0 billion in a $24.3 billion global market for ophthalmic drugs.
NCX 470 is designed to release both bimatoprost and NO after instillation into the eye. Bimatoprost, marketed under the brand name LUMIGAN® by Allergan, Inc., is a leading product in the prostaglandin analog class, the most widely used drug class for lowering IOP in patients with open-angle glaucoma or ocular hypertension. About Nicox Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve eye health. Nicox’s lead clinical development program is NCX 470, a novel nitric oxide-donating prostaglandin analog intended to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for dry eye. Nicox derives revenue from VYZULTA® in glaucoma, under exclusive worldwide license to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, under license in several geographies, including Eyevance Pharmaceuticals, LLC, in the United States and Ocumension Therapeutics in China and the majority of Southeast Asian markets.
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment C: Mid Caps; Ticker: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indices.
For more information about Nicox, its products or its pipeline, please visit: www.nicox.com. Analyst coverage
Bryan, Garnier & Co Dylan van Haaften Paris, France
Edison Investment Research Pooya Hemami London, United Kingdom
HC Wainwright & Co Yi Chen New York, USA
Kepler Cheuvreux Damien Choplain Paris, France The opinions expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. In addition, the information contained in their reports may not be correct or up to date. Nicox disclaims any obligation to correct or update information contained in analyst reports. contacts
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